The Under-funded, Under-staffed FDA
Just yesterday, Ted Frank suggested that I was wrong, and the FDA wasn't suffering from staffing and funding problems. Just hours later, the Associated Press posts an article explaining that yes, the FDA is under-staffed and under-funded. And the pharmaceutical industry shares part of the blame:
WASHINGTON (AP) -- When pharmaceutical consulting firm Quintiles wants to hire a new employee, the first place it looks is the Food and Drug Administration.
These former insiders bring critical expertise to the consultant and clients like Merck & Co. Inc. and Pfizer Inc., but there is also an unintended downside.
As companies siphon off FDA's most experienced scientists, they leave an increasingly leaner, less confident staff that is hesitant to put new drugs on the market, analysts say.
"What you have now is a big sucking sound of these staffers leaving FDA and going into the more lucrative side of the business or packing it in and retiring entirely," said Steve Brozak, an analyst with WBB Securities. "This cannot have any positive effect whatsoever."
FDA has repeatedly rejected criticisms from Wall Street and pharmaceutical companies that drug approvals have slowed in recent years. Instead, the agency says companies are submitting fewer new drug applications.
FDA's leadership is scrambling to recruit a new generation of food and drug regulators, as the average age of FDA's 10,100-person work force reaches 54. Thirty percent of the agency's regular staff are already eligible to retire and FDA expects to hire 600 staffers by October to replace those leaving. (Emphasis added.)
FDA's outside advisers say frustration with FDA culture is a major reason its turnover rate is twice that of other agencies.
Staffers who disagree with management are reportedly discouraged from speaking up, according to an Institutes of Medicine report on FDA's drug safety system. (Emphasis added.)
FDA's outside advisers point the blame for staffing problems toward the White House and Congress, which have heaped new responsibilities on the agency without increasing its funding.
In the last 15 years, FDA has received more than 100 new assignments, but the number of government-provided staffers has fallen from roughly 9,000 to 8,000. The result is less regulation even as the industries FDA oversees grow larger. (Emphasis added.)
The image of an overburdened agency has not made things easier for FDA recruiters, who are crisscrossing the country seeking applicants with science backgrounds.
At the center of the staffing effort is a proposed fellowship program that would bring 2,000 scientists and doctors into the agency every two years, with the goal of convincing some to stay on.
But with no funding set aside for the program, even those pulling for FDA are skeptical. (Emphasis added.)
"If you look at the 20,000 medical students graduating each year, only a very small portion would even be interested in a career that leads to a government agency," said Michael Ehlert, president of the American Medical Student Association.
The danger of dwindling inspections hit home earlier this year when FDA said contaminated heparin from Baxter International Inc. was associated with as many as 81 deaths and hundreds of allergic reactions.
FDA didn't inspect the Chinese plant where the blood thinner was produced due to a bureaucratic mix-up involving a factory with a similar name.
While FDA records list 3,249 foreign drug manufacturers subject to inspections, it can't tell if it has inspected two thirds of them, according to Government Accountability Office investigators.
The agency may soon get an injection of much-needed funds. (Emphasis added.)
After weathering nearly weekly scoldings from lawmakers, FDA Commissioner Andrew von Eschenbach asked Congress last month for an emergency $275 million to supplement this year's $2.3 billion fiscal budget. (Emphasis added.)
So to recap: The FDA is short on money and staff. Much of the staff that it does have lacks the necessary skills and experience to (a) approve drugs in a timely manner and (b) protect the public from unsafe products and facilities. Because the pharmaceutical industry pays much better than government, it's doubtful that the FDA will be able to attract and retain the top-notch doctors and scientists it needs to fulfill its mission. A mission that has expanded dramatically without any concomitant increase in funding or staff, by the way.
Articles like this illustrate why FDA preemption is a bad idea. If we're going to put the FDA completely in charge of drug safety and eliminate the tort system, shouldn't we make sure that the agency has the right people and the right amount of funding to protect the public?